The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Anti-saccharomyces Cerevisiae Antibody (asca) (igg).
| Device ID | K032850 |
| 510k Number | K032850 |
| Device Name: | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) |
| Classification | Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) |
| Applicant | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 |
| Contact | Kevin Lawson |
| Correspondent | Kevin Lawson IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 |
| Product Code | NBT |
| CFR Regulation Number | 866.5785 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-12 |
| Decision Date | 2004-03-18 |